Identifiers
- 510(k) Number
- K183062 FDA 510(k)
- FDA Product Code
- DQX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Asahi Silverway Guide Wire is a guide wire designed for intravascular use, classified under product code DQX. It is engineered to facilitate the introduction and engagement of angiographic catheters within coronary arteries, supporting diagnostic and interventional procedures.
This device is supplied sterile and intended for single-use via femoral or radial access routes. It is regulated under the FDA’s 510(k) pathway with a traditional review process, classified as substantially equivalent (SESE) under the Cardiovascular (CV) advisory committee. Compliance with the Medical Devices Directive (MDD) is also noted. The device is manufactured by Asahi Intecc Co., Ltd., Japan.
Frequently asked questions
What is the Asahi Silverway Guide Wire primarily used for in clinical procedures?
The Asahi Silverway Guide Wire is designed to assist in the introduction and positioning of angiographic catheters within coronary arteries. It supports both diagnostic and interventional procedures, making it useful for guiding catheters through femoral or radial access routes during coronary interventions.
Is the Asahi Silverway Guide Wire intended for single-use or can it be reused?
The Asahi Silverway Guide Wire is explicitly supplied for single-use only, as stated in its specifications. Reuse is not recommended or supported by the manufacturer.
How is the Asahi Silverway Guide Wire regulated in the U.S. and Europe?
In the U.S., the device is cleared through the FDA’s 510(k) pathway with a traditional review process, classified as substantially equivalent (SESE) under the Cardiovascular (CV) advisory committee. It also complies with the Medical Devices Directive (MDD) in Europe.
What access routes can the Asahi Silverway Guide Wire be used with?
The device is engineered for use via femoral or radial access routes, allowing flexibility in procedural approaches for coronary artery interventions.
Is the Asahi Silverway Guide Wire sterile when supplied?
Yes, the Asahi Silverway Guide Wire is supplied sterile, ensuring readiness for immediate clinical use without additional sterilization steps.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ASAHI Silverway® | Asahi Intecc Medical, ASAHI Silverway | Medical products for Coronary | ASAHI INTECC PRODUCTS, Asahi Intecc Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K183062 | Class II | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
Sources (2)
- FDA 510(k) K183062 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026